Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users

Combination of 0.09% Cyclosporine and Intense Pulsed Light (IPL) Therapy for the Treatment of Dry Eye Disease in Symptomatic Contact Lens Wearers: a Sham-Controlled Randomized Clinical Trial

Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users (NCT06392438) is a Phase 3 interventional studying Dry Eye and Contact Lens Complication, sponsored by Université de Sherbrooke. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

In this study, two treatments typically used for dry eye disease will be tried for contact lens users to see if their symptoms when they use their contact lenses get better. Cyclosporine is a drop that is used for long-term management of the inflammation and Intense pulsed light (IPL) is a treatment done in a clinic to improve the health of the eyelid glands. The main question in this study is: Does the combined treatment of cyclosporine and IPL improve the symptoms and the dry eye signs of contact lens wearers? All the participants will receive the cyclosporine drops for 4 months twice a day. The research team will split the group of participants in two, half receiving the real IPL treatment and half receiving a sham IPL treatment during the last two months of the study. This will allow to compare the two groups to see how IPL helped. The dry eye tests will be done at the start of the study, after two months and after 4 months. The tests will include a dry eye symptoms questionnaire, measures on the tears, the structures of the front of the eye and the eyelids.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Dry Eye, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 44 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Soft silicone-hydrogel contact lens wearers - Monthly, 2-weeks, opr daily replacement schedule of contact lens - Minimum wear of contact lens for 1 day/week and 4 hours consecutive - f-CLDEQ-8 score ≥ 12 Who Should NOT Join This Trial: - Past usage of cyclosporine 0.09% (Cequa) - Use of another ophthalmic cyclosporine drop in the past 6 months - Known intolerance to cyclosporine - Pregnancy or breastfeeding (or planned pregnancy in the duration study) - History of ocular herpes simplex infection - Active ocular infectious condition - Usage of photosensitizing medication - Epilepsy - History of skin cancer in the IPL treatment zone - Tattoo/pigmented lesion/keloid scars in the IPL treatment zone - Refractive surgery in the past 12 months - In-clinic thermal pulsation eyelid treatment in the past 12 months - Usage of glaucoma drops - Regular continuous wear of contact lenses (including sleep) - Excessive movement or decentration of the contact lenses (assessed at first visit) - Giant papillary conjunctivitis Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Soft silicone-hydrogel contact lens wearers * Monthly, 2-weeks, opr daily replacement schedule of contact lens * Minimum wear of contact lens for 1 day/week and 4 hours consecutive * f-CLDEQ-8 score ≥ 12 Exclusion Criteria: * Past usage of cyclosporine 0.09% (Cequa) * Use of another ophthalmic cyclosporine drop in the past 6 months * Known intolerance to cyclosporine * Pregnancy or breastfeeding (or planned pregnancy in the duration study) * History of ocular herpes simplex infection * Active ocular infectious condition * Usage of photosensitizing medication * Epilepsy * History of skin cancer in the IPL treatment zone * Tattoo/pigmented lesion/keloid scars in the IPL treatment zone * Refractive surgery in the past 12 months * In-clinic thermal pulsation eyelid treatment in the past 12 months * Usage of glaucoma drops * Regular continuous wear of contact lenses (including sleep) * Excessive movement or decentration of the contact lenses (assessed at first visit) * Giant papillary conjunctivitis

Treatments Being Tested

DRUG

CycloSPORINE Ophthalmic

Unidose of Cequa provided without charge to the participant. 1 drop in each eye morning and evening.

PROCEDURE

Intense Pulsed Light

Appropriate eye patches and IPL gel will be applied. 15 triggers per passage will be applied from the right temple to the left temple (7 shots from the right temple to the right nose wing, 1 on the nose bridge and 7 shots from the left nose wing to the left temple). 2 passage/session will be applied.

PROCEDURE

Sham Intense Pulse Light

Appropriate eye patches and IPL gel will be applied. 15 triggers per passage will be applied with the plastic blocker mounted on the IPL prism from the right temple to the left temple (7 shots from the right temple to the right nose wing, 1 on the nose bridge and 7 shots from the left nose wing to the left temple). 2 passage/session will be applied.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Opto-Réseau Sherbrooke Est

Sherbrooke, Quebec, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06392438), the sponsor (Université de Sherbrooke), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06392438 clinical trial studying?

Who can participate in NCT06392438?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06392438?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06392438. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06392438. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.